Date: Sun, 23 Apr 2000 16:54:38 EDT

Dear Friends,

I'm sorry for all this mail, but this is good news. I had contacted several members of Congress a few weeks ago, and I think that was helpful in getting the Democrats more active on this issue. These are the most important Democrats in the House of Representatives regarding the FDA, so this is an important letter. Letters like this one, and the one from Rep. Bliley (the most important Republican in the House re FDA), make me think that letters from constituents now could be more persuasive than usual.

Diana Zuckerman

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April 14, 2000

The Honorable Jane Henney, Commissioner

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland 20857

Dear Commissioner Henney:

Congress has long been interested in assuring that breast implants are safe and effective. Over the last year the Subcommittee on Oversight and Investigations has been looking at FDA's activities regarding the safety of breast implants. In light of the recent testimony before the Food and Drug Administration (FDA) Advisory Panel on Plastic Surgery, combined with the recent press reports concerning the criminal investigation of a breast implant manufacturer, we request a briefing for Democratic members of the Subcommittee to discuss these and other related matters. By copy of this letter, we are inviting our Republican colleagues on the Subcommittee.

Since the passage of the Medical Device Amendments of 1976, the FDA has had jurisdiction over all medical devices. Current law requires manufacturers of new medical devices to first show that they are safe and effective before they can be marketed. Nevertheless, devices that were in use before 1976, such as breast implants, have been allowed to stay on the market subject to an FDA safety and effectiveness review.

Fifteen years later, in April 1991, the FDA asked manufacturers to submit evidence that silicone gel-filled implants were safe and effective. Initially, due to a lack of data, the FDA determined that breast implants could not be approved. In 1992, gel-filled implants were removed from the market. Nonetheless, citing the strong public health need for gel-filled implants in certain cases, and under the auspices of an adjunct study, FDA decided that silicone gel-filled implants would be available for women with "special needs." These included women who have had breast cancer surgery, a severe injury to the breast, a severe abnormality, or who already had gel implants that needed to be removed. This adjunct study has been running since 1992.

In January 1993, FDA first called for the manufacturers to conduct studies on the safety and effectiveness data on saline-filled implants. Unlike silicone-filled implants, the FDA decided to leave saline-filled implants on the market for "cosmetic" purposes (for all women) while data was being collected. Clinical trials were ordered in 1994 and Pre-Market Applications were eventually submitted to the FDA in November 1999.

At the recent March 1-3 meeting, the advisory panel discussed the research submitted to the FDA in applications by three manufacturers of saline breast implants. It is our understanding that there was significant concern voiced by some in that session regarding the safety and effectiveness of saline-filled breast implants. The panel nonetheless endorsed the applications of two of the manufacturers despite what we understand to be major questions pertaining to the quality of the research, the high complication rate of these products, high failure and re-surgery rates, and testimony showing that saline breast implants can obscure breast tissue and make it more likely that the diagnosis of breast cancer will be delayed.

Although the panel attached a list of conditions which the manufacturers would have to meet if and when the FDA approves saline breast implants, our goal is to make sure that these devices are safe and effective before they are approved by FDA. We are concerned that post-market conditions would give manufacturers insufficient incentive to improve their product, after their applications are approved by FDA.

While we are very sensitive to making sure that breast cancer survivors have access to implants for breast reconstruction, we are also concerned about how the FDA has handled this issue since the 1976 Amendments. Frankly, the variety of concerns about the FDA's oversight of the adjunct study, review of adverse events reported to FDA, the reportedly open criminal investigation into allegations relating to one of the sponsors, and the recent meeting of the advisory board, do not engender confidence in the minds of patients, legislators, or the public.

It would be exceedingly unfortunate if FDA rushed its review of this matter only to contribute to the lingering perception by many that its handling of the entire breast implant matter has been less than adequate. Therefore, we request a briefing from you and Dr. David Feigal on these matters in early May. To schedule the briefing, please have your staff contact Christopher Knauer of the Minority staff at (202) 226-3400.

Sincerely,

JOHN D. DINGELL, RANKING MEMBER

COMMITTEE ON COMMERCE

RON KLINK, RANKING MEMBER

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

cc: The Honorable Tom Bliley, Chairman

Committee on Commerce

The Honorable Fred Upton, Chairman

Subcommittee on Oversight and Investigations

Diana Zuckerman, Ph.D.

Executive Director

National Center for Policy Research for Women and Families

1444 Eye Street, NW Suite 900 Washington, DC 20005

202 216-9507